TPLC - Total Product Life Cycle

show TPLC since

Device	system, catheter control, steerable
Product Code	DXX
Regulation Number	870.1290
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	25	25
Device Displays Incorrect Message	5	5
Component or Accessory Incompatibility	3	3
Component Falling	3	3
Fail-Safe Problem	3	3
Device Operates Differently Than Expected	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Insufficient Information	2	2
Electrical Shorting	2	2
Display or Visual Feedback Problem	2	2
Electrical /Electronic Property Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Break	2	2
Detachment Of Device Component	2	2
Bent	1	1
Thermal Decomposition of Device	1	1
Computer Operating System Problem	1	1
Loss of Data	1	1
Communication or Transmission Problem	1	1
Mechanical Problem	1	1
Loss of Power	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Issue	1	1
Patient Device Interaction Problem	1	1
Activation Problem	1	1
Fail-Safe Did Not Operate	1	1
Power Problem	1	1
Device Operational Issue	1	1
Device-Device Incompatibility	1	1
Human-Device Interface Problem	1	1
Inadequate User Interface	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	24	24
No Patient Involvement	20	20
No Consequences Or Impact To Patient	14	14
No Clinical Signs, Symptoms or Conditions	4	4
Pericardial Effusion	2	2
Fistula	2	2
Vertigo	1	1
Chest Pain	1	1
Death	1	1
Electric Shock	1	1
Foreign Body In Patient	1	1
Movement Disorder	1	1
Speech Disorder	1	1
Paresthesia	1	1
Insufficient Information	1	1
Vascular Dissection	1	1
No Code Available	1	1